ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097668
• Other study ID #: ATX-MS-1467-002
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2010
• Last updated: February 3, 2015
• Start date: March 2010
• Est. completion date: July 2013

Study information

• Verified date: February 2015
• Source: Apitope Technology (Bristol) Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyRussian Republic: Ministry of Health and Social Development of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with relapsing forms of multiple sclerosis. This will be an open label upward dose titration involving injections on 9 occasions, each two weeks apart. After dosing is complete there will be a 22 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections and MRI scans will be performed on several occasions to follow the course of the multiple sclerosis during the trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 1. Patients who have definite relapsing multiple sclerosis disease as defined by the McDonald criteria (McDonald et al., 2001 and 2005) and as assessed by a neurologist.

2. HLA DRB1*15 positive.

3. High baseline levels of T-cell proliferation in response to myelin basic protein, defined as >1000 cpm with a >3 stimulation index compared to background.

4. Disease duration equal to or less than 10 years (from the first clinical event).

5. At least one documented relapse in the previous 12 months or two relapses within the previous 24 months prior to screening.

6. Must be in a clinically stable or improving neurological state during the 28 days preceding Screening.

7. EDSS score < 5.5.

Exclusion Criteria:

• 1. Subjects treated with ß-interferon, plasma exchange, intravenous gamma globulin within the 3 months prior to Study Day 1 2. Subjects treated with glatiramer acetate at any time in the past 3. Subjects who have been treated with parenteral steroids or adrenocorticotropic hormone within 3 months days prior to Study Day 1 4. Prior treatment with: cytotoxic agents (including but not limited to cladribine, mitoxantrone, cyclophosphamide, azathioprine, methotrexate), fingolimod, laquinimod, teriflunomide, total lymphoid irradiation, stem cell or bone marrow transplantation, or monoclonal antibody therapy (including natalizumab, daclizumab, alemtuzumab) 5. Prior use of disease related T-cell vaccine or peptide-tolerising agent to treat MS

6. Use of any investigational drug or experimental procedure within 6 months prior to Study Day 1 including cytokine or anti-cytokine therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• ATX-MS-1467
Disease specific immune modulating treatment for multiple sclerosis

Locations

Country	Name	City	State
Russian Federation	Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology	Chelyabinsk
Russian Federation	State Medical Institution "Republican Clinical Hospital of rehabilitation treatment of Ministry of Healthcare of Tatarstan Republic", Republican clinicodiagnostic center of demyelinating diseases of Ministry of Healthcare of Tatarstan Republic	Kazan
Russian Federation	State Educational Institution of Higher Professional Education "1st Moscow State Medical University n.a. I.M. Sechenov of Ministry of Healthcare and Social Development of the Russian Federation, Department of new drugs research	Moscow
Russian Federation	State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology	Rostov-on-Don
Russian Federation	LLC "International Clinic MEDEM", Department of functional diagnostics	Saint Petersburg
Russian Federation	State Educational Institution of Higher Professional Education "St. Petersburg State Medical University n.a. I.V. Pavlov of Roszdrav", Department of neurology with clinic	Saint Petersburg
Russian Federation	State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery	Samara
Russian Federation	State Educational Institution of Higher Professional Education Saratov State Medical University	Saratov
Russian Federation	State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Roszdrav", Department of neurology and neurosurgery based at State Healthcare Institution "Smolensk Regional Clinical Hospital"	Smolensk
Russian Federation	Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory	St Petersburg
Russian Federation	St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2	St Petersburg
United Kingdom	National Hospital for Neurology & Neurosurgery	London
United Kingdom	Queen's Medical Centre	Nottingham
United Kingdom	Peninsula Medical School	Plymouth
United Kingdom	Royal Hallamshire Hospital	Sheffield
United Kingdom	North Staffordshire Royal Infirmary	Stoke on Trent	Staffordshire

Sponsors (3)

Lead Sponsor	Collaborator
Apitope Technology (Bristol) Ltd.	Aptiv Solutions, ClinStar, LLC

Countries where clinical trial is conducted

Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.	48 weeks	Yes
Secondary	The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).	Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.	16 and 20 weeks	Yes

External Links

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